Pain Measurement Tools and Methods, Ambulatory Blood Pressure Monitoring and Questionnaires in Clinical Research –Overview

Download Article


Authors : Praneeth Kamarapu

Abstract:

An Expert Working to review the status of the use of pain measurement tools (PMTs), Ambulatory blood pressure monitoring (ABPM) and Questionnaires in Clinical Research. The present work recommends that standardized methods should be applied for the use of PMTs in research. Unidimensional pain measurement tools (PMTs) and multidimensional pain measurement tools (PMTs) designed to assess pain, the McGill Pain Questionnaire and Brief Pain Inventory are valid in many multilingual versions.

The diagnosis and management of hypertension is based on blood pressure (BP) measurements taken by doctors or nurses with conventional sphygmomanometers. Asking the patient to take their own BP at home has been sporadically reported for many years, but the potential value of patient home measurement has been overshadowed by the development of continuous ambulatory BP monitoring.

Ambulatory blood pressure monitoring have been shown to improve the management of hypertension. Twenty practices were asked to monitor hypertensive patients, in particular those about to start drug treatment and those who were poorly controlled.

A good questionnaire design for a clinical trial will minimize bias and maximize precision in the estimates of treatment effect within budget. The mode of administration can also impact on the cost, quality and completeness of data collected. There is good evidence for design features that improve data completeness but further research is required to evaluate strategies in clinical trials. Theory-based guidelines for style, appearance, and layout of self-administered questionnaires have been proposed.

KEYWORDS: pain measurement tools (PMTs), Ambulatory blood pressure monitoring (ABPM), Questionnaire design, Mode of administration, Guidelines.

References:

[1.] Brown, G.E. (1930). Daily and monthly rhythm in the blood pressure of a man with hypertension: a three year study. Ann Intern Med, 9, 1177-1189.

[2.] Bullinger, M., Alonso, J., Apolone, G., et al. (1998). Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International quality of life assessment. J Clin Epiderm, 51, 913–923.

[3.] Burns–Cox, C. J., Russell, Rees, J., Wilson, R.S.E. (1975). Pilot study of home measurement of blood pressure by hypertensive patients.

[4.] Clark, C.W., Ferrer-Brechner, T., Janal, M.N., et al (1989). The dimensions of pain: a multidimensional scaling comparison of cancer patients and healthy volunteers. Pain 37, 23–32.

[5.] Cleeland, C. S. (1984). The impact of pain on the patient with cancer. Cancer, 54, 2635–2641

[6.] Cleeland, C. S. (1989). Measurement of pain by subjective report In: Chapman CR, Loeser JD, eds. Advances in pain research and management, vol 12. Issues in pain management. New York: Raven Press, pp 391–403.

[7.] Daut, R. L., Cleeland, C.S. (1982) the prevalence and severity of pain in cancer. 50, 1913–1918.

[8.] De, Wit, R., Huijer, Abu-Saad, H., Loonstra, S., et al. (1999). Empirical comparison of commonly used measures to evaluate pain treatment in cancer patients with chronic pain. J Clin Oncol, 17, 1280–1287.

[9.] Deschamps, M., Band, P.R., Coldman, A. J. (1988). Assessment of adult cancer pain shortcoming of current methods. Pain, 32, 133–139.

[10.]         Design and use of questionnaires: a review of best practice applicable to surveys of health service sta_ and patients", Health Technology Assessmen,.(2001), Vol 5, No 31.

[11.]         Feine, J.S, Lavigne, G.J, Thuan, Dao, T. T, et al. (1998). Memories of chronic pain and perception of relief. Pain, 77, 137–141.

[12.]         Fishman, B., Pasternak, S., Wallenstein, S. L, et al. (1987) The Memorial Pain Assessment Card: a valid instrument for the evaluation of cancer pain. Cancer, 60, 1151–1158.

[13.]         Galer, B. S., Jensen, M., P. (1997). Development and preliminary validation of a pain measure specific to neuropathic pain. Neurology, 48, 332–338.

[14.]         Gracely, R. H., McGrath, P. A, Dubner, R. (1978). A ratio scales of sensory and affective verbal pain descriptors. Pain, 5, 5–18.

[15.]         Gracely, R. H., McGrath, P. A., Dubner, R. (1978). Validity and sensitivity of ratio scale of sensory and affective verbal pain descriptors: manipulation of affect by diazepam. Pain, 5, 19–29.

[16.]         Haynes, Sackett, D. L., Gibson, E. S., et al.(1976).Improvement in medication compliance in uncontrolled hypertension. Lancet, 119, 1034-1039.

[17.]         Houde, R. W., Wallenstein, S. L., Beaver, W. T. (1965). Clinical measurement of pain. In: de Stevens G, ed. Analgesics. New York: Academic Press, 75–122.

[18.]         Houde, R. W., Wallenstein, S. L., Beaver, W. T. (1966). Evaluation of analgesics in patients with cancer pain. In: Lasagna L, ed. International encyclopedia of pharmacology and therapeutics, vol 1. New York: Pergamon Press, 59–67.

[19.]         Jensen, M. P., Karoly, P., Braver, S. (1986). The measurement of clinical pain intensity: a comparison of six methods. Pain, 27, 117–126.

[20.]         Jensen, M. P., Karoly, K. (1993) Measurement of cancer pain by self report. In: Chapman CR, Foley KM, eds. Current and emerging issues in cancer pain: research and practice. New York: Raven Press, 193–218.

[21.]         Jensen, M. P., McFarland, C. A. (1993). Increasing the reliability and validity of pain intensity measurement in chronic pain patients. Pain, 55, 195–203.

[22.]         Jensen, M. P., Turner, J. A., Romano, J. M. (1994). What is the maximum number of level needed in pain intensity measurement? Pain, 58, 387–392.

[23.]         Julius, S. (1991). Home blood pressure monitoring: advantages and limitations. J Hypertens, 9(3), S41-46.

[24.]         Kerns, R.D., Turk, D.C., Rudy, T.E. (1985). The West Haven Yale multidimensional pain inventory (WHYMPI). Pain, 23, 345–356.

[25.]         Kleinert, H. D., Harsh, G. A., Pickering, T. G., et al (1984). What is the value of home blood pressure measurement in patients with mild hypertension? Hypertension, 6,574-578.

[26.]         Kremer, E. F., Atkinson, J. H., Ignelzi, R. J. (1981). Measurement of pain: A patient preference does not confound pain measurement. Pain, 12, 153–163.

[27.]         Littman, G. S., Walker, B. R., Schneider, B. E. (1985). Reassessment of verbal and visual analog ratings in analgesic studies. Clin Pharmacol Ther, 38, 16–23.

[28.]         Mancia, G., Sega, R., Bravi, C., et al (1995). Ambulatory blood pressure normality: results from the PAMELA study. J Hypertens, 13, 1377-1390.

[29.]         McQuay, H., Moore, A. (1998). An evidence-based resource for pain relief. Oxford: Oxford University Press, 9(6), 41-49.

[30.]         O’Brien, E., O’Malley, K. (1988). Over diagnosing hypertension, 297, 1211.

[31.]         O’Brien, E. T., Beevers, D. G., Marshall, H. J. (1995). ABC of Hypertension [Third edition.] London: BMJ Publishing Group.

[32.]         O’Brien, E., Mee, F., Atkins, N., Thomas, M. (1996). Evaluation of three devices for self measurement of blood pressure according to the revised British Hypertension Society Protocol: The Omron HEM-705 CP,Philips HP5332 and Nissei DS-175. Blood Pressure Monitoring, 55-61.

[33.]         Pickering, T. G. (1987). Ambulatory blood pressure monitoring as a predictor of cardiovascular risk. Am Heart J, 114, 925-928.

[34.]         Pickering, T. G. (1993). Blood pressure variability and ambulatory monitoring. Curr Opin Nephron Hypertens, 2, 380-385.

[35.]         Price, D. D, McGrath, P. A., Rafi, A., Buckingham, B. (1983). The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain, 17, 45–56.

[36.]         Price, D. D., Bush, F. M., Long, S., Harkins, S. W. (1994) A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain, 56, 217–226.

[37.]         Questionnaire Design by Cathy Jenkins and Mario Davidson

[38.]         Rinck, G. C., van den, Bos, A.M., Kleijnen, J., et al. (1997). Methodologic issues in effectiveness research on palliative cancer care: a systematic review. J Clin Oncol, 15, 1697–1707.

[39.]         Sauders, C., Doyle, D., Hanks, G. W. C., and eds. (1998). Oxford textbook of palliative medicine, 2nd ed. Oxford: Oxford University Press. V–IX.

[40.]         Scott, J., Huskinsson, E. C. (1976). Graphic representation of pain. Pain, 2, 175–184.

[41.]         Sever, P., Beevers, G., Bulpitt, C., et al. (1993). Management guidelines in essential hypertension. Report of the second working party of the British Hypertension Society, 306, 983-987.

[42.]         Seymour, R. A., Simpson, J. M., Charlton, J. E., Philips, M. E. (1985). An evaluation of the length and end-phrase of visual analogue scales in dental pain. Pain, 21, 177–185.

[43.]         Soghikian, K., Casper, S. M., Fireman, B. H., et al. (1992). Home blood pressure monitoring. Effect on use of medical services and medical care costs. Med Care, 30, 855-865.

[44.]         The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. (JNCVI.) Arch Intern Med 1997. 157, 2413-2446.

[45.]         Wallenstein, S. L. (1975). Analgesic studies of aspirin in cancer patients. Proceedings of the Aspirin Symposium. London: Aspirin Foundation, 5–10.

[46.]         Wallenstein, S. L., Houde, R. W. (1975). The clinical evaluation of analgesic effectiveness. In: Ehrenpreis S, Heidle A, eds. Methods of narcotic research. New York: Marcel Dekker, 127–145.

[47.]         Wallenstein, S. L., Heidrich, G. I., Kaiko, R., Houde, R. W. (1980). Clinical evaluation of mild analgesics: the measurement of clinical pain. Br J Clin Pharmacol, 10, 319S–327S.

[48.]         Wallenstein, S. L. (1991). Commentary: the VAS relief scale and other analgesic measures: carryover effect in parallel and crossover studies. In: Max MB, Portenoy RK, and Laska EM, Eds. The design of analgesic clinical trials, vol 18. New York: Raven Press, 97–104.

[49.]         Winer, R. T., Clark, W. C., Keohan, M. L., et al. (1999). Validation of the multidimensional affect and pain questionnaire (MAPS) in cancer patients. 9th World Congress on pain. Vienna: IASP Press, 214.